| CTRI Number |
CTRI/2024/08/072648 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Magnesium sulphate as an adjuvant for spinal anaesthesia in Preeclamptic patients : A study on its effects |
|
Scientific Title of Study
|
Effect of addition of Magnesium sulfate as an adjuvant to intrathecal hyperbaric Bupivacaine -fentanyl in patients with preeclampsia without severe features undergoing caesarean section - A Prospective Randomized controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nrutvi Gajera |
| Designation |
Resident doctor in Department of Anaesthesia |
| Affiliation |
Goverment Medical college Baroda |
| Address |
Government Medical College , Baroda Vadodara GUJRAT
Vadodara
GUJRAT
390001
India
Vadodara
GUJARAT
390001
India |
| Phone |
7043425581 |
| Fax |
|
| Email |
nrutvigajera1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Darshna Patel |
| Designation |
Associate Professor |
| Affiliation |
Goverment Medical college Barioda |
| Address |
Government Medical College , Baroda Vadodara GUJRAT
Vadodara
GUJRAT
390001
India
Vadodara
GUJARAT
390001
India |
| Phone |
9925013155 |
| Fax |
|
| Email |
dr.darshna1968@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Darshna Patel |
| Designation |
Associate Professor |
| Affiliation |
Goverment Medical college Barioda |
| Address |
Government Medical College , Baroda Vadodara GUJRAT
Vadodara
GUJRAT
390001
India
Vadodara
GUJARAT
390001
India |
| Phone |
9925013155 |
| Fax |
|
| Email |
dr.darshna1968@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology SSG Hospital Vadodara 390001, Gujrat , India |
|
|
Primary Sponsor
|
| Name |
Goverment Medical college Baroda |
| Address |
Department of Anaesthesiology New surgical block SSG Hospital Vadodara 390001 , Gujrat , India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nrutvi Gajera |
SSG Hospital Vadodara |
1st floor, labour room Rukmani Chainani Prasuti Gruh ,Department of obstetrics and gynaecology SSG Hospital Vadodara 390001 , Gujrat , India
Vadodara
GUJARAT |
7043425581
nrutvigajera1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for biomedical and health research ,government medical college baroda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O140||Mild to moderate pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Addition of magnesium sulphate to intrathecal hyperbaric bupivacaine -fetanyl |
After preanesthetic evaluation patients meeting inclusion criteria will be selected .
operation theatre with all necessary equipments and drugs to be kept ready
spinal anaesthesia will be given in l3- L4 intervertebral space. patients will be randomly devided into two groups . In this group Group BFM - Bupivacaine heavy 0.5% 2ml + fentanyl 25 mcg 0.5 ml + preservative free 50%magnesium sulphate 50 mg 0.1 ml total 2.6 ml drug volume given in spinal anaesthesia . patient will be turned supine and wedge will be placed under right hip then intraioperative vital monitoring , spinal and motor blockade , duration analgesia ,requirement of rescue analgesia will be assessed for 24 hours |
| Comparator Agent |
Addition of preservative free saline to intrathecal hyperbaric bupivacaine -fetanyl |
After preanesthetic evaluation patients meeting inclusion criteria will be selected . operation theatre with all necessary equipments and drugs to be kept ready spinal anaesthesia will be given in l3- L4 intervertebral space. patients will be randomly devided into two groups . In this group Group BFM - Bupivacaine heavy 0.5% 2ml + fentanyl 25 mcg 0.5 ml + preservative free saline 0.1 ml total 2.6 ml drug volume given in spinal anaesthesia . patient will be turned supine and wedge will be placed under right hip then intraioperative vital monitoring , spinal and motor blockade , duration analgesia ,requirement of rescue analgesia will be assessed for 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant female with preeclampsia without severe features (systolic bp 140-160 mmhm and diastolic bp 90-110 mmhmg)
2. pregnant women with mild preeclampsia without severe features posted for elective caesarean section to be operated under spinal anaesthesia
3.pregnant women with mild preeclampsia without severe features having height ranging between 150 to 170 cm and weight ranging between 50 to 90 kg |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Patient with contraindication to spinal anaesthesia like allergy to local anaesthetics drug ,local infection ,raised intracranial pressure, spinal deformity , coagulopathy
3.Pregnant women with coexisting systemic disorders
4.Pregnant women taking magnesium therapy
5.Eclampsia
6. Psychiatric illness
7. active labour, twin pregnancy ,complicated pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| No. of Requirement of rescue analgesia |
Till 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Duration of post operative analgesia
2.Changes in hemodynamic parameters perioperartively
3.observe spinal block characteristics
4. observe any complications like bradycardia , hypotension ,respiratory depression , pruritic , nausea , vomiting
|
Till 24 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
27/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of study is to evaluate the effect of adding magnesium sulphate intrathecally to bupivacaine - fentanyl combination in patients with preeclampsia without severe features undergoing caesarean section.
90 pregnant women with preeclampsia without severe features will be randomly decided into two groups , In each group there will be 45 patients who are posted for elective caesarean section .
In one group Group Bf - Bupivacaine heavy (0.5% ) 2 ml + fentanyl 25mcg ( 0.5 ml ) + Preservative free saline 0.1 ml = total 2,6 cc drug volume given in second group Group BFM - Bupivacaine heavy (0.5%)2ml + fentanyl 25 mcg (0.5 ml ) +Preservative free 50 % magnesium sulphate 50 mg 0.1 ml = total 2.6 cc drug volume given
Requirement of rescue analgesia over 24 hours as primary outcome As a secondary outcome ,Duration of post operative analgesia till 24 hours , hemodynamic parameters , spinal block characteristics ,any complications will be assessed .
The proposed advantage of the study will be that the addition of intrathecal magnesium sulphate to combination of bupivacaine -fentanyl in patients with preeclampsia without severe features undergoing caesarean section will lead to prolong duration of postoperative analgesia as well as reduced requirement of rescue analgesia with minimal side effects .
|